Kornimate/medical-research-clean huggingface dataset:
joint health study

Conditions: Hemophilia B

Summary: this is a prospective, non-randomized, controlled study to examine whether or not having a higher trough during prophylactic treatment with clotting factor offers better joint protection than the standard trough of 1% factor ix (fix or factor 9). this study will test the hypothesis that an extended half-life (ehl) fix product with an intended trough of \>10% could offer better protection than previous treatment concentrates. this study also examines whether or not joint damage could be diagnosed earlier using ultrasound images.

this is a prospective, non-randomized, controlled study to examine whether or not having a higher trough during prophylactic treatment with clotting factor offers better joint protection than the standard trough of 1% factor ix (fix or factor 9). this study will test the hypothesis that an extended half-life (ehl) fix product with an intended trough of \>10% could offer better protection than previous treatment concentrates. this study also examines whether or not joint damage could be diagnosed earlier using ultrasound images. the primary research question is whether ehl rix with an intended trough level of \>10% will improve the outcome of joint health of elbow, ankle, and knee joints as assessed with ultrasound assessments in patients with severe hemophilia b. depending on their current treatment regimen, subjects will be in one of three groups: 1) on demand, 2) prophylaxis with an intended trough of 1-5%, and 3) prophylaxis with an intended trough of \>10%. subjects will have four annual study visits over three years: baseline, year 1, year 2, and year 3. at each of these visits, subjects will complete questionnaires, joint assessments, have their blood taken, and have ultrasound images of their joints. the first 10 subjects will also have x-rays and mris of their joints for ultrasound validation. subjects are encouraged to come in during a painful episode for an examination, assessment, and ultrasound of their joints and to come in again within 1-2 weeks after the painful episode for a repeat examination, assessments, and ultrasound. this study will be conducted at the washington center for bleeding disorders (wcbd) at bloodworks northwest, oregon health \& science university (ohsu), university of california san diego (ucsd), university of california los angeles (ucla), and tulane university (tu). cumulatively across the five sites, up to 50 participants will be enrolled. additional sites may be added.

Eligibility criteria:
inclusion criteria: * severe hemophilia b (fix \<1%) * either on demand or on prophylaxis with rfix or ehl-rix products with the intention to stay on the current regimen for the next 3 years * for group c, start of this treatment regimen up to 6 months prior is permissible exclusion criteria: * other known bleeding disorder * other rheumatologic disorder affecting joints * other known neuromotor defect (making physical exam difficult)

Keywords: hemophilia b fix factor ix factor 9
phase i study of episcleral celecoxib for treatment of macular edema and inflammatory disorders of the posterior pole

Conditions: Macula Edema; Radiation Retinopathy; Branch Retinal Vein Occlusion; Epiretinal Membrane; Central Serous Retinopathy With Pit of Optic Disc; Commotio Retinae; Vitritis

Summary: this phase i trial will assess primarily the safety and secondarily the anti-inflammatory and anti-neovascular effect of episcleral celecoxib in patients suffering from macular edema and other inflammatory disorders of the retina, choroid and vitreous.

this phase i trial will assess primarily the safety and secondarily anti-inflammatory/neovascular effect of episcleral celecoxib in patients suffering from macular edema \& inflammatory disorders of the eye posterior pole including sclera, choroid, retina, or vitreous. celecoxib is a specific cyclooxygenase-2 inhibitor that possesses anti-angiogenic, anti-inflammatory, and anti-fibrotic properties. non-clinical studies have documented the activity of celecoxib in reducing leakage of the blood-retina barrier as well as inhibiting vascular endothelial growth factor (vegf) and prostaglandin e2 (pge2) expression in the retina of diabetic rats. the underlying mechanisms for its anti-inflammatory and anti-angiogenic properties have been extensively characterized. the investigators hypothesize that episcleral celecoxib is safe, tolerable and that its anti-inflammatory/anti-neovascular activity will reduce macular edema and improve vision in patients with macular edema. objective: to primarily assess the safety, tolerability and pharmacokinetics of episcleral celecoxib in patients with macular edema and other inflammatory disorders of the posterior pole including retina, choroid and vitreous to secondarily assess efficacy in reducing macular edema and improving visual function. methods: the main outcome of the study is safety assessment. secondary outcomes are assessment of visual acuity and anatomical changes in the macula as measured via optical coherence tomography (oct).

Eligibility criteria:
inclusion criteria: * age \>= 18 years; * visual acuity letter score in study eye \< 70 and ≥ 25 letters (approximate snellen equivalent 20/32 to 20/320); * ophthalmoscopic evidence of center-involved macular edema, within the central subfield (csf); • inflammatory disorders of the sclera, choroid, retina or vitreous exclusion criteria: * inability to understand informed consent, cooperate with testing or return to follow up visits; * pregnant or lactating women; * co-existent ocular disorder of the cornea, lens or media that will interfere with assessment of safety or efficacy.

Keywords: macula edema radiation retinopathy branch retinal vein occlusion epiretinal membrane central serous retinopathy with pit of optic disc commotio retinae vitritis
nerve transfer after spinal cord injuries

Conditions: Spinal Cord Injury

Summary: nerve transfer surgery can provide improved hand function following cervical spinal cord injuries

current treatment strategies of acute cervical spinal cord injuries remain limited. treatment options that provide meaningful improvements in patient quality of life and long-term functional independence will provide a significant public health impact. specific aim: measure the efficacy of nerve transfer surgery in the treatment of patients with complete cervical spinal cord injuries with no hand function. optimize the efficiency of nerve transfer surgery by evaluating patient outcomes in relation to patient selection and optimal timing the the surgery. hypothesis: peripheral nerve transfers in patients with spinal cord injuries will improve hand function and provide improvement in patient quality of life and functional independence.

Eligibility criteria:
inclusion criteria: 1. 18-65 years of age 2. informed consent document (icd) signed by patient 3. cervical spinal cord injury resulting in arm \& hand functional impairment, with at least preserved elbow function 4. international classification of surgery of the hand in tetraplegia (icsht) category 0 - 4 5. patients with a stable american spinal injury association (asia) grade of a, b, or c, or with a diagnosis of central cord syndrome, showing minimal to no evidence of functional improvement in motor examination after at least 6 months of non-operative therapy post-injury 6. appropriate candidate for nerve transfer study 7. willing and able to comply with the study protocol 8. \< 48 months from injury exclusion criteria: 1. active infection at the operative site or systemic infection 2. any return or ongoing clinical recovery of distal motor function within 6 months after injury 3. physically or mentally compromised 4. currently undergoing long-term steroid therapy 5. significant joint contractures and/or limitations in passive range of motion in the arm or hand 6. active malignancy 7. systemic disease that would affect the patient's welfare or the research study 8. pregnant 9. immunologically suppressed or immunocompromised 10. significant pain or hypersensitivity 11. previous or current injury preventing use of tendon transfers to restore upper extremity function 12. affective disorder of a degree that would make outcome assessment and study participation difficult 13. history of brachial plexus injury or systemic neuropathic process

Keywords: spinal cord injury nerve transfer tetraplegia quadriplegia
combination chemotherapy plus filgrastim in treating patients with hiv-related non-hodgkin's lymphoma

Conditions: Lymphoma

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. combining more than one drug may kill more cancer cells. colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. purpose: phase i/ii trial to study the effectiveness of combining filgrastim with combination chemotherapy in treating patients who have hiv-related non-hodgkin's lymphoma.

objectives: * determine the toxicity of mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, prednisolone, and filgrastim (g-csf) in patients with good-prognosis (defined by the study as having 1 adverse prognostic factor) hiv-related non-hodgkin's lymphoma. * determine the effects of this regimen on response rate, time to disease progression, and survival in these patients. outline: this is a multicenter study. patients receive mitoxantrone iv, cyclophosphamide iv, and etoposide iv on day 1; and vincristine iv and bleomycin iv on day 8. patients also receive prednisolone daily on weeks 1-4 and then every other day on weeks 5-16. patients receive filgrastim (g-csf) subcutaneously on days 6-12. treatment repeats every 2 weeks for up to 8 courses (16 weeks) in the absence of disease progression or unacceptable toxicity. patients with complete response (cr) or partial response (pr) receive 4 courses beyond cr or pr. patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. projected accrual: a total of 15-30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed previously untreated hiv-related non-hodgkin's lymphoma with 1 of the following: * prior diagnosis of acquired immune deficiency syndrome (aids) * cd4 count \< 100,000/mm3 * ecog performance status \> 2 patient characteristics: age: * 18 and over performance status: * see disease characteristics life expectancy: * not specified hematopoietic: * see disease characteristics hepatic: * not specified renal: * not specified prior concurrent therapy: biologic: * not specified chemotherapy: * not specified endocrine: * not specified radiotherapy: * not specified surgery: * not specified

Keywords: aids-related peripheral/systemic lymphoma aids-related primary cns lymphoma aids-related diffuse large cell lymphoma aids-related immunoblastic large cell lymphoma aids-related small noncleaved cell lymphoma aids-related diffuse mixed cell lymphoma aids-related diffuse small cleaved cell lymphoma aids-related lymphoblastic lymphoma
diagnosis of lynch syndrome based on next-generation sequencing in patients meeting chinese lynch syndrome criteria

Conditions: Lynch Syndrome

Summary: the purpose of this study is to find out the proportion of patients diagnosed with lynch syndrome in colorectal cacner patients meeting chinese lynch syndrome criteria. besides, this study is aimed to analyze the clinical characteristics and germline mutation of lynch syndrome in chinese population.

1. detect germline mutation (by next-generation squencing) in probands. 2. verify the germline mutation in blood relatives whose proband has known germline mutation(s). 3. analyze the test data with clinical and family information. diagnose lynch syndrome in the included population. 4. analyze the clinical characteristics and germline mutation of lynch syndrome in chinese population.

Eligibility criteria:
for probands, the inclusion criteria： all of the following three points should be satisfied: 1. one of the colorectal cancer patients from families meeting chinese lynch syndrome criteria. chinese lynch syndrome criteria: in a pedigree, there were at least 2 patients with histological-proven colorectal cancer, and among these, at least two patients are first-degree relatives of each other. besides, any one of the following three points should be satisfied in the pedigree: a. at least one patients with multiple primary colorectal carcinoma/adenoma, either synchronously or metachronously. b. at least one colorectal cancer diagnosed before 50 years old. c. in the pedigree, at least one patient diagnosed with other lynch syndrome associated cancer (ie, gastric, endometrial, small bowel, ureter, or renal-pelvic, ovarian and hepatobiliary cancers). 2. with sufficient blood to test; 3. agree to provide basic information, clinical information and family history of cancer information. for probands, the exclusion criteria: with at least one blood relative with known pathogenic germline mutation(s). for blood relatives verifying germline mutation, the inclusion criteria： all of the following three points should be satisfied: 1. first- to second-degree blood relatives of probands with germline mutation(s). 2. with sufficient blood to test. 3. agree to provide basic information, clinical information and family history of cancer information. for blood relatives verifying germline mutation, the exclusion criteria: blood relatives who refuse to test.

Keywords: lynch syndrome next-generation sequencing germline mutation
effects of a berry oil cream on atopic eczema and skin

Conditions: Atopic Dermatitis Eczema

Summary: atopic eczema is a chronic inflammatory skin disease associated with itch and inflammatory lesions in typical skin areas. the objective of this study is to investigate the effects of a cream containing berry and plant oils and humectants on atopic eczema and dry skin.


Eligibility criteria:
inclusion criteria: * atopic eczema (mild or medium severity) exclusion criteria: * other serious skin conditions (for example psoriasis) * known hypersensitivity to ingredients of the study creams * medication seriously affecting immune function
phase iv-cervical dystonia-interest in cd2

Conditions: Cervical Dystonia

Summary: the purpose of the study is to document long-term response in real-life practice after injection cycles with bont-a in subjects suffering from idiopathic cervical dystonia (long-term clinical and pharmaco-economic data).


Eligibility criteria:
inclusion criteria: * subject for whom there is an intention to treat with bont-a. * bont treatment naïve or previously treated with bont. * if previously treated with bont, at least a 12-week interval between the last injection (bont-a or bont-b) and inclusion. * subject able to comply with the protocol. * provision of written informed consent prior to collect the data. exclusion criteria: * contraindications to any bont-a preparations. * the subject has already been included in the study.
irreversible electroporation(ire) for unresectable prostatic neoplasms

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (ire) for unresectable prostatic neoplasms.

by enrolling patients with unresectable prostatic neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous ire for unresectable prostatic neoplasms.

Eligibility criteria:
inclusion criteria: * prostatic neoplasms diagnosed by positive biopsy or non-invasive criteria, * not suitable for surgical resection, * eastern cooperative oncology group (ecog) score of 0-1, * a prothrombin time ratio \> 50%, * platelet count \> 80x10\^9/l, * ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post nanoknife procedure, * able to comprehend and willing to sign the written informed consent form (icf), * have a life expectancy of at least 3 months. exclusion criteria: * cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * any active implanted device (eg pacemaker), * women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the nanoknife™ ledc system, * are in the opinion of the investigator unable to comply with the visit schedule and protocol evaluations.

Keywords: irreversible electroporation unresectable prostatic neoplasms
efficacy of raltegravir in a large urban hiv clinical population in milan

Conditions: HIV Infections

Summary: this will be a retrospective analysis of efficacy, safety and tolerability of raltegravir as part of an optimized therapy in a clinical setting. follow-up is calculated from the treatment initiation (with or without raltegravir) up to the date of discontinuation of the considered regimen or the date of last visit or the date of lost to follow-up, whichever came first. the aim of the study is to evaluate the efficacy and safety of raltegravir-containing regimens in a urban clinic setting.


Eligibility criteria:
inclusion criteria: * subjects who received raltegravir and were previously exposed to nrtis, nnrtis, pis, regardless of the stage of hiv disease at the start of the treatment. exclusion criteria: * none

Keywords: raltegravir efficacy safety raltegravir-containing regimens hiv urban clinic setting
compliance of clinical pathways in elective laparoscopic cholecystectomy: evaluation of different implementation methods

Conditions: Gallstones

Summary: compliance to the clinical pathway, postoperative complication and total cost of the hospitalisation of patients undergoing elective cholecystectomy for symptomatic cholecystolithiasis were collected over two different periods: using a clinical pathway in form of a paper based check-list (group 1, n=118) or a clinical pathway integrated into the paper based medical treatment and nursing documentation (group 2, n=123). outcome measures were compliance of the clinical pathway and total costs per case.

data of patients undergoing elective cholecystectomy for symptomatic cholecystolithiasis were collected over two different periods: a clinical pathway in form of a paper based check-list (check-list group, n=118, or in form of a clinical pathway integrated into the paper based medical treatment and nursing documentation (integrated clinical pathway group, n=123. a standardized clinical pathway for elective laparoscopic cholecystectomy in form of a check list was initially established in 2008 and evaluated during a 6-month period (august 2011 until january 2012) at the university of tuebingen. the integrated clinical pathway was evaluated during a 6-month period after an introduction phase of 2 months (november 2012 until april 2013). the contents of both clinical pathways were identical, especially concerning the standardization of perioperative fluid management, perioperative monitoring, nutrition, analgesia, reserve medications, preoperative and postoperative examinations, detailed laboratory blood testing, nursing standards and planned discharge. primary outcome measure was the compliance to the clinical pathway defined as an adherence of more than 80% to the presetted pathway items.

Eligibility criteria:
inclusion criteria: * patients undergoing elective laparoscopic cholecystectomy exclusion criteria: * emergency procedures * conversion to open cholecystectomy

Keywords: cholecystectomy, check list
peri-operative vasopressor support in patients operated for an acute hip fracture (ahf)

Conditions: Hip Fractures; Intraoperative Hypotension

Summary: the incidence of hypotension perioperatively during operation of an acute hip fracture is unknown. as a surrogate factor the usage of vasopressor support is more adequate as the registration of vasopressor drugs are many times not complete in records. the investigators retrospectively investigated the anesthetic journals of 1100 patients with an acute hip fracture (ahf) noting confounding factors and the usage of vasopressors either by injections or infusions and then correlated these results to mortality at 30-, 90- and 365- days

the incidence of hypotension perioperatively during operation of an acute hip fracture is unknown. as a surrogate factor the usage of vasopressor support is more adequate as the registration of vasopressor drugs are many times not complete in records. the investigators retrospectively investigated the anesthetic journals of 1100 patients with an acute hip fracture (ahf) noting confounding factors and the usage of vasopressors either by injections or infusions and then correlated these results to mortality at 30-, 90- and 365-days confounding factors were; all comorbitity, age, asa grade as well as type of anesthesia

Eligibility criteria:
inclusion criteria * patients with an acute hip fracture exclusion criteria * only one fracture within time-limit. * unretreivable mortality data
a retrospective study reveals the relationship between gp42-igg epitopes and ebv-associated npc

Conditions: Nasopharyngeal Carcinoma

Summary: epstein-barr virus (ebv) infection is a necessary factor of nasopharyngeal carcinoma (npc). the incidence of npc in endemic regions reaches 24.60/100,000 people, far higher than that of the worldwide average. however, no ebv prophylactic vaccines is clinically available so far, which is largely hampered by the difficulties in selecting optimal vaccine design target out of 13 glycoproteins on the surface of ebv. in this study, we utilized humanized gp42-igg antibodies to explore the dominant epitopes of gp42, one of the functional ebv glycoproteins during virus entry, to facilitate prophylactic vaccine design.


Eligibility criteria:
inclusion criteria: * controls underwent physical examinations or primary npc cases confirmed by pathology or cytology. * if cases, at stage i-ivb diagnosed by radiology according to ajcc/uicc 8th. * if cases, karnofsky score (kfs)≥70, estimated survival span\>12 months. * if cases, no disordered of major organs is found; blood test, liver, and kidney functions are basically normal. * if cases, at least one measurable lesion according to response evaluation criteria in solid tumours (recist) 1.1. exclusion criteria: * history of other malignant diseases. * history of severe systemic diseases or heart, lung, liver, or kidney disfunction. * history of severe neurological, metal, endocrine diseases. * history of hbv, hcv, hiv, tp, or tb infection. * if controls, physical examination reveals systemic diseases including malignant diseases. * if cases, incomplete blood and pathological sample data. * if cases, not receiving primary treatment in this facility. * other individuals investigators find not suitable for the trial.